Job Description

The

Microbiologist

will be responsible for ensuring the microbiological quality and sterility assurance of orthopedic implants, surgical instruments, and cleanroom environments. The role involves monitoring sterilization processes, performing environmental and bioburden testing, and supporting validations in compliance with ISO 13485 and regulatory standards.

Key Responsibilities

Perform

bioburden testing

,

sterility testing

, and

endotoxin (LAL) tests

on implants and instruments. Conduct

environmental monitoring

of cleanrooms (settle plates, air sampling, surface & personnel monitoring). Validate

sterilization cycles (ETO/Gamma)

and maintain sterilization records. Support validation and routine control of

cleanroom facilities

. Ensure adherence to

ISO 13485

,

ISO 14644

, and other relevant standards. Prepare and maintain microbiological test reports, SOPs, and control documents. Investigate microbial contamination incidents and implement corrective actions. Support audits and inspections by regulatory bodies or clients.

Qualifications & Experience

Education:

B.Sc. / M.Sc. in Microbiology / Biotechnology.

Experience:

2-5 years in microbiology or sterility assurance in a

medical device, pharma, or orthopedic implant

industry.

Knowledge:

Microbial testing methods (USP, ISO standards). Environmental monitoring procedures. Cleanroom and sterilization process validation.

Key Skills

Strong documentation and analytical skills. Familiarity with laboratory instruments and aseptic techniques. Attention to detail and GMP compliance mindset. Ability to support audits and technical documentation.
Job Type: Full-time

Pay: ₹20,000.00 - ₹35,000.00 per month

Work Location: In person